Exopharm Limited (ASX:EX1) has achieved critical results from its PLEXOVAL II phase I safety study with the company’s off-the-shelf (allogeneic) platelet-derived EV product, Plexaris.
New studies found there were no untoward or unexpected safety events reported during the study with all 11 enrolled participants remaining healthy throughout and after their 30-day follow- up period.
These results confirm Exopharm as a leader in EV medicine manufacture and further validate our LEAP manufacturing technology,” said Founder and Managing Director, Dr Ian Dixon.
“Forty clinical-grade doses of Plexaris were made within eight hours by two staff. If the study had been 100 times larger, it still would have taken the same amount of time and labour, only larger equipment.
“This is what we mean when we say LEAP is the only fully- scalable process for exosome purification that has been developed. This manufacturing capability is fully applicable to our engineered EV programme, as this manufacturing process and the safety of product coming out of it is applicable to all EV medicines processed with LEAP.”
Dr Dixon said all induced wounds successfully healed without skin defects, abnormal scarring or abnormal cosmetic appearance. Due to the small numbers involved in the study there are no significant efficacy signals.
The phase 1 study demonstrated the safety of off-the-shelf Plexaris in a cutaneous wound healing condition, concluding that there are no safety risks associated with the use of the product or the injection of the product.
The first-in-human study of Plexaris was a prospective randomised double-blind, placebo-controlled study aimed at demonstrating the safety of the product administered to healthy adult volunteers as a single dose subcutaneously at the site of a skin punch biopsy-induced wound.
Dr Angus Tester, Exopharm’s Head of Product Evaluation said the results from this study are very encouraging and are consistent with preclinical testing and the expected safety profile of a purified platelet product.
“This is an important milestone proving Exopharm’s manufacturing capability of a medical-grade product.”
The clinical-grade doses of the Plexaris EV product were produced using Exopharm’s LEAP technology and purification process, demonstrating and further credentialing the company’s technical and manufacturing capabilities. These doses also included our new formulation IP, giving a 12-month shelf-life under -80°C storage conditions.
Traditional therapeutics derived from human blood and plasma already play a critical role in health care worldwide and represent over US$30 billion per annum in sales. With Exopharm’s EV purification technology, blood service organisations and blood plasma companies could add high-value products to their distribution channels and help thousands of patients.
“Platelets (the starting material for Plexaris) are derived from blood donors every day around the world and are used as an unmatched product with a strong safety record. Commercialising Plexaris through blood services organisations will enable the future exploration of its efficacy for a variety of medical conditions. We look forward to advancing the use of blood-derived EVs globally in the coming years,” said Aislinn Treloar, one of Exopharm’s Business Development Managers.
